This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

Rate of complete molecular response (CMR). Levels of BCR-ABL transcripts will be determined by RQ-PCR testing of peripheral blood and analysed at an appropriate national EUTOS reference laboratory. [ Time Frame: after 18 months of study drug ] [ Designated as safety issue: No ]

CMR is defined as undetectable BCR-ABL transcripts by quantitative RT-PCR in a peripheral blood sample of at least 10 ml with a minimum sensitivity of 1:10,000.

Secondary Outcome Measures:

Rate of early progression to accelerated phase and blast crisis in year 1 and 2 and the rate of events in patients achieving a CMR at 1 year [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]

The rate of MMR at, as well as by, 12 and 24 months; the rate of CCyR at, as well as by , 12 and 24 months; the rate of CHR at, as well as by, 12 and 24 months [ Time Frame: at as welll as by 12 and 24 months ] [ Designated as safety issue: No ]

The rate of early events, event free survival, overall survival; and safety and tolerability of nilotinib [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]

Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome

Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible

WHO performance status 0-2

Laboratory assessments within normal limits

Written informed consent prior to any study procedures being performed

Exclusion Criteria:

Known impaired cardiac function

History of acute or chronic pancreatitis

Impaired gastrointestinal function or disease that may alter the absorption of study drug

Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)

Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug

Other protocol-defined inclusion/exclusion criteria may apply

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01061177